One of the greatest challenges in healthcare is keeping up with the changing landscape. Considering only since the beginning of 2019, the Centers for Medicare and Medicaid Services (CMS) and other federal agencies, such as the Office of National Coordinator of Health IT (ONC) and the Department of Health and Human Services (HHS), have introduced a number of rules as a measure of upholding their goal of empowering patients and enhancing healthcare efficiency. We’re at a very critical juncture in healthcare and from a regulatory perspective, there are a few key rules that merit a special focus which will have a great impact from both a clinical and financial standpoint.
The MyHealthEData Initiative in 2019
The MyHealthEData initiative, launched in March 2018, aims to “empower patients by ensuring that they control their healthcare data and can decide how their data is going to be used, all while keeping that information safe and secure.” Only a few days back, CMS upped the ante for better data access by expanding this initiative and announcing the pilot of “Data at the Point of Care.”
The Data at the Point of Care (DPC) pilot will be connecting providers with Blue Button data, where providers can access claims data to learn more about their patients and their previous diagnoses, procedures, and prescriptions. While providers had to comb through several hundred data sets previously, the DPC program would aim to make access to data easier and right within their workflows.
This announcement follows the relaunch of the Blue Button initiative, or Blue Button 2.0, that grants access to health data and enables patients to send that information using FHIR-based healthcare apps.
In a nutshell, these moves come as an overall push from CMS to promote better access to data and 100% healthcare interoperability. In addition to enabling data access, CMS has also been targeting information blocking, as reflected by 2019 MyHealthEData updates. With these measures, both patients and providers will have the required insights to make more informed healthcare decisions.
The Trusted Exchange Framework and Common Agreement
In April 2019, ONC published its second draft of the Trusted Exchange Framework and Common Agreement (TEFCA), focusing on three high-level goals:
Providing a single ‘on-ramp’ to nationwide connectivity
Enabling Electronic Health Information (EHI) to securely follow the patient wherever needed
Supporting nationwide scalability
TEFCA is basically a common set of principles which serve as “rules of the road” for nationwide electronic health information exchange across disparate health information networks (HINs). The framework, which was mandated by the 21st Century Cures Act, provides a set of policies and procedures along with technical standards required to enable healthcare data exchange among providers, state and regional HINs, and federal agencies.
By Scott E. Rupp, publisher, Electronic Health Reporter.
On March 21 HIMSS representatives vice president of government affairs, Tom Leary, and senior director of federal and state affairs, Jeff Coughlin, hosted a roundtable with members of the media to peel back a few layers of the onion of the newly proposed ONC and HHS rules to explain some of the potential ramifications of the regulations should they be approved.
The CMS proposed regulation is attempting to advance interoperability from the patient perspective, by putting patients at the center of their health care and confirming that they can access their health information electronically without special effort.
ONC’s proposed regulation calls on the healthcare community to adopt standardized application programming interfaces (APIs) and presents seven reasonable and necessary conditions that do not constitute information blocking.
According to HIMSS’s assessment of both proposals there’s room for interpretation of each, but the organization has not yet fully formed a complete response to each as of this writing.
Tom Leary
However, Leary said: “It’s important to emphasize that all sectors of the healthcare ecosystem are included here. The CMS rule focuses on payer world. The ONC rule touches on vendors and providers. All sectors really are touched on by these rules.”
With both, ONC and CMS is trying to use every lever available to it to push interoperability forward and is placing patients at center, Coughlin said. The healthcare sector got a taste of how CMS plans to empower patients through its recent MyHealthEData initiative, but the current proposal places more specifics around the intention of agency. Likewise, the ONC rule is attempting to define the value of the taxpayer’s investment in regard to the EHR incentives invested in the recent meaningful use program.
Key points of the rules
Some key points to consider from the rules: APIs have a role to play in future development of the sector and are seen as a real leveler of the playing field while providing patients more control of their information, Coughlin said.
HHS is focusing on transparency and pricing transparency. For example, there’s movement toward a possibly collecting charge master data from hospitals and, perhaps, publishing negotiated rates between hospitals and payers, which HHS is looking into.
Jeff Coughlin
What happens now that rules are out? According to HIMSS, education members is the first step to understanding it and responding to the federal bodies. “What we’ve done is focus on educating HIMSS members in briefings,” Coughlin said. “Trying to get early feedback and early impressions from members, convening weekly conference calls to address parts of the rule. Once we have critical mass then we work with executive leadership to make sure what we are hearing from membership to is reflected across the membership.”
Looking into the future?
For health systems, the broad exchange of data likely remains a concern. Data exchange within the ONC rule impacts providers and health systems in a number of ways, especially in regard to the costs of compliance to meet all of the proposed requirements.
HIMSS representatives are not currently casting a look into a crystal ball or if they are (they are), they’re not yet ready to tip their hand regarding what the organization intends to pursue through its messaging on behalf of its members.
“We’re not in a place to see where we are going to land,” Coughlin said. “We are hearing from our members about the complexities of rules and what’s included. It’s hard to overestimate how complex this is. ONC and CMS in designing broader exchange of information is something that speaks very well of them, but (this is) complex in interpretation and implementation.”
Information blocking exceptions, the default is broader sharing of information across the spectrum. More information has to be shared and expectations need to be defined, they said. From HIMSS’ perspective, compliance is the primary issue of its members. The question that needs answering is what kind of burden is being placed on health systems and providers. Leary is confident HIMSS will spend a good bit of ink in its response on citing potential concerns over information blocking and what that might mean.
“It will be helpful for the community to have examples and use cases for what’s included especially for exceptions for information blocking,” Coughlin said. “We need examples to clearly define the difference between health information exchange and health information network.”
On March 21 HIMSS representatives vice president of government affairs, Tom Leary, and senior director of federal and state affairs, Jeff Coughlin, hosted a roundtable with members of the media to peel back a few layers of the onion of the newly proposed ONC and HHS rules to explain some of the potential ramifications of the regulations should they be approved.
